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Director, Regulatory Affairs

Company: Disability Solutions
Location: Raritan
Posted on: June 1, 2024

Job Description:

Employer: Janssen Research & Development, LLC Job Title: Director, Regulatory Affairs Job Code: A011.5200 Job Location: Raritan, NJ Job Type: Full-Time Rate of Pay: $230,000 - $263,000 Job Duties: Responsible for the development, implementation, and maintenance of robust Global / North American regulatory strategies. Lead the Global Regulatory Team and be a key contributor on multiple cross-functional teams, such as Compound Development Team (CDT). Provide strategic direction to the teams. Provide critical reviews of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing, and supplemental applications. Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned). Lead and/or participate in meetings with FDA, Health Canada, EMA, and other Health Authorities (HAs) as appropriate. Develop a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified. Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards. Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs, as well as addendums & supplements. Serve as primary point of contact for US FDA. Lead the regulatory response team for FDA and Health Canada questions. Ensure US Business Partners are consulted and given input into US regulatory strategies, PMR fulfillments, and other US-related issues. Manage routine maintenance submissions. Manage and track NA post-approval commitments. Provide input and review submission documents, as well as approve submissions before dispatching to regulatory authorities. Contribute to the development of the USPI. Lead the development of NA labelling negotiation strategies and development of supporting documentation for labelling. Review FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct. May telecommute from anywhere in the U.S.

Keywords: Disability Solutions, New Brunswick , Director, Regulatory Affairs, Executive , Raritan, New Jersey

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